ML26007A127

MOC Process Description and Examples

ML26007A127
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Issue date:	01/07/2026
From:	Office of Nuclear Reactor Regulation
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1 Regulatory Collaboration Process and Benefits

Purpose:

This document describes how CNSC, NRC and ONR work together to collaboratively review advanced reactor designs, provides an example demonstrating the benefits of collaboration to regulators and industry, and shows how another regulator can leverage the work through the example of ONRs experience. A flowchart of the collaborative process is included as an enclosure.

Collaboration Process Criteria for participation Effective cooperation requires that all regulators have the information needed to perform reviews. A prerequisite to collaborating on a specific design is that the vendor has appropriate agreements with each regulator to provide sensitive information. To avoid the challenges of exchanging sensitive and proprietary information between regulators, the vendor is responsible for submitting to each regulator the information that is within the scope of collaboration via the appropriate submission processes. Information developed by the regulators as part of the collaborative reviews is also controlled and shared through secure channels.

The decision to propose cooperation on a specific design is that of the vendors, made with consideration for their commercial plans in each country. The timelines for, and scope and depth of regulatory interactions with the regulators should be considered when proposing projects. In addition, cooperation must acknowledge the differences in the U.S., Canadian and UK regulatory frameworks and licensing processes, as well as the outcomes or products desired by the vendors in each country. For example, the objectives of the CNSCs vendor design review process are different than those of the NRCs certification and pre-licensing engagement processes, yet opportunities exist for leveraging information between the two regulators. Even in areas where the licensing process or outputs differ, cooperation can leverage the fundamental scientific and engineering findings by each regulator to the extent that it is practical to do so.

In general, a request by vendors to participate in cooperation is made because they have already substantially engaged with at least one of the regulators and that they have known plans to engage with another regulator on the same design. Through the MOC, the regulators have established criteria to strategically select licensing projects that are at similar phases of submittal in each agency and have actively engaged with vendors to ensure that the requests to all regulators are similar enough to allow for a joint review. The decision to cooperate on a licensing project is based on the following factors:

- The extent to which the vendor is engaging in meaningful pre-licensing activity with each regulator

- The similarity between the vendors engagement activities in each country

- The timelines for engaging with each regulator

- The ability of the vendor to share information about their design with both regulators These factors will determine whether cooperation can occur, and the usefulness of the cooperation. For example, the timing of vendor submittals will impact whether the activity will be mutually beneficial to the regulators to collaborate on the review. The most benefit will be gained through projects for which the submittals in each country are well-aligned. For misaligned projects (for example, if one regulator has completed its review of a design area while the other has not

2 started) the regulators may focus on information sharing, rather than developing joint conclusions.

Communication between the vendor representatives in each country is also important. The vendors in each country should be able to collaborate effectively with each other and speak with one voice.

Project Selection Projects are established under the MOC with specific goals and products. These projects may have generic applicability such as the comparison of licensing processes or development of positions on technical topics. Other projects aim to cooperate on the review of a specific design.

Each project has a schedule and timeline that supports the review schedules of each regulator.

Once a design is chosen for collaboration, the regulators, in cooperation with the vendor, identify specific technical topics for reviews. Generally, these areas are the subject of topical reports or white papers that have been submitted. Recognizing that the regulatory requirements will not always align, collaboration should focus on the technical content that ultimately satisfies both countries unique requirements.

The regulators work with the vendors as active participants in the collaborative process.

Vendors are strongly encouraged to have a point of contact for activities in all countries to represent the vendor in collaborative activities. Communication protocols are established and standardized at the beginning of the project. Vendors must be enabled with a working understanding of how both regulators conduct their pre-licensing regulatory activities and what the outcomes of those processes are. The regulators work together to reach alignment with the vendor on the scope of collaboration and establish an understanding on how this collaboration can result in both near term and long-term useful products. The regulators clearly communicate the expectations of the vendors that are considered necessary to facilitate an efficient and productive collaboration process.

Types of Collaboration The type of collaboration is decided by the MOC Committee and is dependent on the stage of review for each regulator and the expected outcome. If a regulator would benefit from understanding the regulatory decisions made by another regulator on a specific topic, but is not currently reviewing that topic, they may observe meetings and audits of the other regulator.

If one regulator has completed reviews of a topic and other regulators would benefit from understanding the decisions that were made and the reasons, information sharing may be the most useful form of collaboration. The regulator who has completed its review will make its documents available to the others and the regulators may meet to discuss the conclusions.

If two or more regulators are at similar stages of review for a topic, the topic would benefit from the most formal type of collaboration - a joint review that results in a joint product. This type of collaboration involves development of a work plan.

Work plans Work plans are created to guide each project by identifying the objective and scope of the project, the expected outputs, the work process and schedule, points of contact in each agency and external organizations that will be involved, and other related international work in the technical area. The work plans ensure that both agencies are aligned on the expectations up front and have

3 committed the necessary resources to perform the joint review. In carrying out the collaborative reviews, the regulators may hold joint meetings with vendors or applicants, participate in audits led by the other regulator, issue a joint set of questions to the vendor or applicant, or provide training on licensing processes and technical issues.

Products The product of the cooperation projects is usually a joint report that is developed, reviewed, and signed by all involved regulators. The joint report will record the positions and observations that both agencies agree to, as well as any differences in positions and limitations for use of the report. If the project is a review of a vendor submittal requesting a regulatory decision (i.e., a topical report, or license application) the regulators will provide separate safety evaluations or letters to their respective vendors in response to the submitted documents. These safety evaluations or letters can reference information in the joint report. Templates were created to provide consistency in the format of the joint reports, and a desk guide provides guidance to the regulators on conducting joint reviews and issuing joint products. Lessons learned are consistently collected and addressed to improve the process.

Example: BWRX-300 Containment Evaluation Method The following provides an example of how CNSC and NRC collaborated on a speci"c topic to the bene"t of the regulators and industry.

GEH submitted a topical report on containment evaluation as part of pre-application activities in the U.S. and the vendor design review in Canada and requested a joint review by CNSC and USNRC staff.

This was the "rst joint review for the BWRX-300 where various joint activities were piloted including:

Development of a joint work plan Joint participation in audits and technical meetings Sharing of information on computer codes TRACG and GOTHIC Pilot staff exchange Publication of a joint report with joint conclusions, limits and conditions As the "rst joint review for the BWRX-300, this project served as a vehicle to establish a range of capabilities under the MOC, pilot joint activities, incorporate lessons learned and serve as a blueprint for subsequent collaborations. The following bene"ts were experienced:

Bene"ts to regulator Access to NRC training on BWR technology streamlined CNSC staff familiarization at the pre-licensing stage and contributed to efficiencies when reviewing OPGs licence to construct application.

The joint report informed CNSC staff recommendation to Commission which resulted in the issuance of a licence to construct in 30 months.

4 The joint conclusions including licensing considerations provided for a focused technical review plan and roadmap for lifecycle regulatory oversight for construction and operation The joint report provides a starting point for future regulators reviewing BWRX-300 (ie. ONR)

Bene"ts to industry GEH was able to apply a common methodology to both regulatory jurisdictions to be implemented by OPG and TVA The joint conclusions, limits and conditions provided regulatory predictability for the vendor to prepare its technical submissions to support subsequent licensing phases The joint report demonstrated that while there are similarities and differences between the US and Canadian regulatory frameworks, a common safety case and technical basis can be used to support each countrys respective process and independent decision-making Bene"ts to ONR joining the MOC later On the basis that US NRC and CNSC had reviewed the application of the TRACG and GOTHIC codes against comparable standards relating to veri"cation and validation, ONR judged it not necessary to undertake its own independent checks. This saved time, resources and cost for both ONR and GE Hitachi, whilst still allowing the ONR to reach an underpinned conclusion on a fundamental aspect of the BWRX-300 safety case.

The available reviews of the other regulators helped target ONRs assessment towards areas of uncertainty and signi"cance, reducing the time necessary to identify these areas and facilitating a review on accelerated timescales.

Leveraging MoC work from an ONR perspective CNSC and NRC started joint working arrangements on BWRX-300 in March 2023. In March 2024 ONR signed a memorandum of cooperation (MoC) with CNSC and NRC, with BWRX-300 immediately being the priority trilateral activity for the three regulators. This is a short summary of the steps that ONR undertook, that may be a template for a future national regulator entering an ongoing joint regulatory project.

The key steps taken by ONR were:

1. Establish the maturity and version of the design, along with the supporting documentation proposed for the UK (compared to that provided or proposed to the other regulators) to understand the applicability of any earlier regulatory judgements or live evaluations to ONR.

2. Identify and review available reports and work ongoing.

3. Provide feedback to CNSC and NRC on initial ONR "ndings from UK submissions.

4. Identify and agree areas for ongoing collaboration

5. Normal business

a. New areas of collaboration managed as part of normal business

b. Maintain communications on any key "ndings/issues These steps are described in detail below:

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1. Establishing the version of design and safety documentation Only the reactor vendor (GE Hitachi) is able to explain what is being proposed for each country, the reference design being considered and the consistency of safety documentation provided to different regulators. In contrast to what has happened with other reactor designs, GE Hitachi endeavoured to maintain and control a single standardized design as much as possible.

However, the design does continue to both mature and evolve, through normal development and interactions with regulators/customers. Safety cases and accompanying analysis also change between countries and over time.

To facilitate meaningful collaboration with CNSC and NRC, clarity on the following was established by ONR from GE Hitachi (documented in submissions and through discussion):

Con"rmation that it was a version of the GE Hitachi maintained standard design that was proposed for regulatory assessment in the UK (as opposed to, for example, the OPG Darlington design)

What the frozen date of the standard design (March 2024) was for the UK design, relative to that considered by CNSC for the construction licence (an earlier version) or NRC (the same as TVA planned to submit in its Clinch River application).

The level of design maturity (BL#) this frozen design represented.

Con"rmation that the UK safety case and supporting analysis was based on the TVA PSAR and not the Darlington PSAR.

Clarity within the submissions provided to ONR on what was unique information for the UK and what was unchanged from the TVA PSAR.

Through an additional report, a summary of regulatory progress and interactions (with speci"c references) in Canada and the US.

This information was not only essential at the start of collaborative activities but throughout. It was repeatedly necessary to seek clarity from GE Hitachi if ONR was assessing information that had not been provided to CNSC in its original submission, or if revised OPG submissions that formed the basis of CNSC decision making had been re"ected in the standard plant design.

2. Identify and review available reports and work ongoing.

In collaboration with CNSC and NRC, ONR identi"ed what regulatory reports were available and what work was ongoing in order to determine how they might be used to support the ONR assessment. In particular ONR was able to bene"t from the work carried out on Advanced Construction Techniques and CNSCs detailed review of the claimed reliability of the BWRX-300s alternative shutdown system.

The easy accessibility of published reports on NRCs website was very helpful. If NRC was not doing this for MOC, later joining regulators would surely ask for something equivalent to be created.

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3. Provide feedback to CNSC and NRC on initial ONR "ndings from UK submissions.

Once ONR had carried out its initial review of the UK submission, it shared high level "ndings with CNSC and NRC. This allowed ONR to con"rm with CNSC and NRC that there were no signi"cant areas of disagreement from a regulatory perspective, taking account of the differences in design maturity and reference point for the safety submissions.

4. Identify and agree on areas for ongoing collaboration CNSC and NRC provided information on ongoing areas of work, which ONR reviewed and identi"ed areas where ongoing collaboration may be bene"cial. This included ongoing interactions such as Break Exclusion Zones (ONR observed a workshop between CNSC and OPG), Advanced Construction techniques (ONR participated in a workshop between CNSC and NRC), core stability (ONR attended a CNSC and NRC seminar featuring an international expert in thermal hydraulics) and C&I (ONR attended a presentation by the reactor vendor to all three regulators on the BWRX-300 C&I design and demonstration of diversity).

5. Normal business New areas of collaboration managed as part of normal business Once ONR was embedded into the MoC structure, decisions on areas of collaboration were taken through the normal MoC business process. For example, ONR developed a workplan on I&C for agreement by the MoC committee and engaged in real time as CNSC raised questions on containment modelling linked to speci"c regulatory holdpoints for the Darlington project.

Maintain communications on any key "ndings/issues ONR provided routine feedback on any "ndings from its assessment, in the same way that CNSC and NRC did. For example, ONR provided feedback from its engagement with GE Hitachi on quality and management arrangements.

The ability to con"rm that "ndings were aligned with those from CNSC was useful and being able to establish that GE Hitachi had taken actions to address "ndings from earlier CNSC engagements was as a valuable con"dence builder.

When ONR concluded the current phase of its review, it informed the other two regulators on the background and details of its conclusions.

Challenges that need to be managed GE Hitachi was the common denominator is all three countries but was not leading the regulatory interactions in most countries.

Projects in individual countries have their own timelines and priorities, which are not established with international collaboration in mind.

7 Submissions and analysis provided to the regulators have to be based on a "xed design and cannot be constantly updated. However, the BWRX-300 design is still maturing and evolving, in part in response to regulatory interactions. The basis for why one regulator reaches a positive conclusion on the design is often on the basis of supplementary information not provided in parallel to the other regulators.

Conclusion The BWRX-300 is a reactor design informed by NRCs long regulatory requirements for BWRs, supported by a safety case developed to IAEA standards which CNSC is taking the lead on assessing. ONRs experience is that this has resulted in a design and safety case that is largely acceptable to it. Joining the collaboration later but still with the ability to check reasoning and history with the home regulator and the lead regulator, was very useful.

Much of the focus of BWRX-300 collaboration has been on areas of novelty and innovation. Access to the regulators views on these matters is very useful, in addition to the broader (vendor/licensee generated) safety case and design which has bene"ted from regulatory intervention and guidance (but for which it is not necessary to see how this was achieved).

At the point at which ONR joined the collaboration, there remained a lot of work for the reactors designers and developers still to do, as well as the regulators. ONR was therefore able to initiate and steer ongoing activities (eg I&C). It is recognised that a regulator joining BWRX-300 collaboration later may not have these opportunities.

The key enablers for ONR joining the regulatory collaboration were 1) its insistence that GE Hitachi clearly set out the consistency and differences between submissions to different regulators, and 2) the reactor vendors ability to provide this information. Baking in this visibility across all design iterations and safety documentation, in all markets would help everyone.